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The Essure Permanent Birth Control System provides women with an alternative to surgical forms of permanent birth control such as tubal ligation. Doctors place two metal coils in the fallopian tubes that form scar tissue, forming a barrier that reportedly is 99.83 percent effective in preventing pregnancy. But thousands of women claim the device caused life-changing injuries and should be pulled from the market.
One of the selling points of Essure is that the procedure is fast. The procedure takes only about 10 minutes in a doctor's office without a need for incisions or anesthesia. In contrast, tubal ligation (tying tubes) requires small cuts and anesthesia. Surgeons can either burn the fallopian tubes shut or clamp them with a small clip.
To insert Essure, the doctor uses a disposable, thin metal catheter containing the compressed Essure coils and inserts them into the body through the vagina. The doctor then positions the coils at the entrance of each fallopian tube and implants them. Once implanted, the coils expand to a length of about 1.5 inches and anchor to the walls of the tubes. One of the most common complaints after the procedure is cramping or mild discomfort similar to what occurs during a woman's monthly cycle. Most women go home and continue normal activities immediately after the procedure.
During the three months following insertion, scar tissue builds around the coils, blocking the fallopian tubes. Women must still use other forms of birth control to prevent pregnancy during this time. A follow-up visit with the doctor can confirm that the fallopian tubes are properly sealed. In some cases, the tissue build-up may take more than three months to complete.
The woman’s ovaries will continue to release eggs once the tubes are blocked, but sperm will not be able to reach them, preventing pregnancy. The body breaks down the unfertilized eggs and reabsorbs them.
Some gynecologists implant Essure while doing other gynecological procedures such as uterine ablation, which is an option for treating heavy menstrual bleeding. Ablation involves burning off the lining of the uterus. Women may still become pregnant however and risk a problematic pregnancy if they do. For this reason, doctors recommend permanent birth control like Essure or tubal ligation.
Not all women have a complication-free experience with Essure. Some women's bodies react poorly to the device. Some report autoimmune problems, migraines, hair loss, perforation of the fallopian tubes or other organs and other issues. In these cases, a regular Essure reversal is not possible because the fallopian tubes and uterus may be too damaged. Surgeons then opt to do a complete hysterectomy.
The long-term effects of hysterectomies can affect a woman's quality of life. For instance, removing the uterus can lead to incontinence, bowel dysfunction, pelvic organ prolapse, sexual problems and the formation of scar tissue in the pelvic organs. Some women receive transvaginal mesh to treat incontinence and prolapse, an implant that may also cause its own complications like organ perforation and severe pelvic pain.
One technique doctors use to perform hysterectomies is called power morcellation. Surgeons use power morcellators, electric, drill-like devices, to chop up the uterus into smaller pieces and remove it from the pelvic cavity. The danger in this technique is that the FDA warned morcellation can spread undiagnosed uterine cancer in the abdomen and pelvic area. So, in addition to issues with Essure it is possible women may face other health problems related to Essure removal.
There are several reported side effects related to Essure. According to Conceptus' premarket application, the majority of women experienced "mild to moderate pain" and spotting for about three days after the procedure.
Initial premarketing studies list the most common adverse events, including:
|Initial studies followed 677 women who used the device, and in the first year they reported the following symptoms:|
|Abdominal cramps||Bloating||Back pain|
|Arm and leg pain||Headaches||Severe cramps|
|Abdominal pain||Vaginal discharge and infection||Heavier periods|
|Abnormal bleeding||Painful intercourse|
The FDA conducted a search of the Manufacturer and User Facility Device Experience database, also known as MAUDE. From November 2002 to May 2015, the agency received 5,093 reports. Most of the reports were voluntary and came from women experiencing problems.
Prior to the FDA panel review of the device in September 2015, the agency said it found 20,000 complaints from women who shared stories on Facebooks and Twitter, ABC News reported. In addition the FDA also saw a "dramatic increase" in reported adverse events in the last two years. In some cases, women may require removal of the inserts.
|The adverse events and the number reported include:|
|Abdominal pain (3,353)||Heavy periods (1,408)|
|Headache (1,383)||Fatigue (966)|
|Weight fluctuations (936)||Device incompatibility, such as possible nickel allergy (941)|
|Device migration (482)||Device operating differently than expected (301)|
|Device breakage (259)||Malposition of device (133)|
In addition to the reported adverse events a handful of deaths are linked to Essure. According to the FDA, five fetuses died as a result of the birth control system. Four women also died from infection, uterine perforation, air embolism and suicide, respectively.
Because Essure is a permanent form of birth control, women who are unsure about wanting more children should not use it.
Essure is also not recommended for use in women who:
Researchers conducted premarket studies on 643 female participants and there were no reported pregnancies. Bayer maintains that Essure is 99.83 percent effective, although the safety and effectiveness of the device was not tested on women younger than 21 or older than 45.
A study conducted in 2014 by Contraception journal questioned the device's efficacy claims. Dr. Aileen Gariepy, assistant professor in the department of gynecology and reproductive sciences at Yale School of Medicine, and colleagues used available published data to determine how effective Essure would be under real-world conditions outside of a lab setting.
Researchers found that nearly 10 percent of women who used Essure could become pregnant. That is four times the risk of pregnancy after tubal ligation, or getting tubes tied, which is the more traditional method of permanent birth control in women.
The FDA approved Essure through a fast-track process with the condition that Conceptus follow study participants for at least four to five years following the procedure, the New York Times reported. The long-term study was finished in 2007, but the data was not published until April 2015 in The Journal of Minimally Invasive Gynecology.
women had hysterectomies after using the device
of participants had unusually heavy periods
suffered from recurrent pelvic pain
reported painful intercourse
Out of the original 518 study participants, 366 were followed for five years. Some of the study findings include:
Bayer would not reveal how many women in the U.S. used Essure, making it difficult for experts to gauge the risk to benefit ratio, the Times reported.
Dr. Gariepy found it troubling that only 70 percent of trial participants were followed for the full five years. "The most common reason patients are lost like this is because they had a problem," she told the Times.
Dr. Mitchell D. Creinin says he believed in Essure when it first hit the market. After witnessing a number of issues from the device, he reevaluated its use in his practice.
"When Essure came out, I was very enamored by it and did a lot of Essures all the time, until I started seeing patients come back with problems and referred to me with complications," Creinin, a professor at U.C. Davis Health System in Sacramento, told the Times.
Women who participated in clinical trials said Conceptus researchers hid their reports detailing how some women suffered severe pain from Essure. Kim Hudak, one of the trial participants, said her answers were altered to get the device approved. Two other women have also come forward, NBC 4 News New York reported.
Hudak told the Times that she suffered from sharp pains, migraines, fatigue and joint pain that interfered with her ability to work. She filed a lawsuit against Bayer for lost wages and suffering.
"It felt like I had a really severe case of the flu, and those were the good days," Hudak said. "I had years and years of doctors telling me I was crazy."
In April 2015, the FDA began an investigation into the allegations that study results were falsified. They found six cases of possible tampering but said it was sporadic and did not reveal a pattern.
After finding thousands of adverse event reports, the FDA called a panel hearing on September 24, 2015. During the meeting, the FDA noted more studies on Essure are needed but did not believe conducting additional trials was feasible, Medscape News reported.
The agency did not ban the device, as some women advocated, but it did issue recommendations. The agency advised that:
Thousands of women who say they suffered complications from Essure are finding it difficult to seek justice through the court system. FDA preemption based on the Medical Device Amendments Act makes suing Bayer difficult. Devices approved under the preemption law are protected from lawsuits because the FDA puts these devices through more rigorous scrutiny.
This has not stopped women from filing lawsuits, and some legal experts say that preemption is not absolute. The FDA received petitions filed by women who say Conceptus — the device's original manufacturer — committed fraud during the premarket approval process and should not be protected. The agency is reviewing these claims.
Bayer continues to stand by the safety and efficacy of its product.